Key Responsibilities:

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDR, and GCP standards. 

• Oversee the creation, updating, and management of QMS documentation, ensuring all processes align with the latest regulatory requirements. 

• Drive internal audits and prepare for external ISO certification audits, ensuring the company meets all necessary compliance standards. 

• Implement and manage quality processes, including CAPA, risk management, and corrective actions, to ensure adherence to ISO 13485 and related standards. 

• Provide training and guidance to staff on ISO requirements and quality best practices, ensuring a company-wide commitment to compliance and quality. 

• Maintain and enhance quality data collection and reporting systems, driving continuous improvement across all functions. 

• Foster and maintain effective working relationships with internal teams and external regulatory bodies to support quality objectives.

Requirements:

• University degree in a scientific field, preferably in chemistry. 

• Extensive knowledge and hands-on experience with ISO 13485, ISO 9001, MDR, and GCP. 

• Several years of quality management experience, ideally within a laboratory environment. 

• Mandatory certification in Quality Management. 

• Proficiency in quality management tools and methodologies, including FMEA, 8D Report, Cause and Effect Diagram, and 5 Why Method. 

• Proven experience in training and mentoring staff on ISO standards and practices. 

• Mandatory certification as an Internal Auditor for ISO standards. 

• Strong attention to detail with excellent organizational skills. 

• Exceptional analytical and problem-solving abilities. 

• Fluent in both English and German 

What We Offer:

• A dynamic and innovative work environment.

• Opportunities to work with leading-edge technology in clinical research.

• Professional development and growth within a fast-growing company.

• Competitive salary, commission structure, and benefits package.

How to Apply:

If you are ready to join a forward-thinking team and help drive the growth of oomnia in the clinical research industry, we want to hear from you. Please share with us your CV and a motivation letter detailing your experience and why you are an excellent fit for this role. Only candidates who provide a motivation letter will be considered.

Deadline for Applications: 31 October 2024